In his order, Judge Jarrod Hazel says that Hospira would likely win its suit because the FDA's decision as "at odds with relevant authority" and "tantamount to a change of the rules."
Generic firm Sandoz (NVS +0.3%) intervened on Hospira's behalf because the ruling would deprive it of the six-month exclusivity it negotiated in its patent infringement settlement with Hospira in December.
Meda AB (OTC:MDABF) agrees to acquire Rottapharm Madaus for 21.2B kronor ($3.1B) adding consumer health products to its portfolio. The deal includes 15.3B kronor in cash, 30M Meda shares and another payment of 2.6B kronor in January 2017.
The Rovati family, who owns 100% of Rottapharm, will own a 9% stake on Meda. Their company, founded in 1961, generated sales of 536M euros ($718M) in 2013.
Earlier this year, Meda rejected a takeover bid from Mylan (NASDAQ:MYL).
The U.S. District for the District of New Jersey grants Mylan's (NASDAQ:MYL) motion for a permanent injunction against GlaxoSmithKline (NYSE:GSK) from supplying Paroxetine CR, the generic form of Glaxo's Paxil CR, to Apotex, which marketed the product. The Court also awards Mylan prejudgment interest and permits it to take an accounting so that it can determine the amount of additional damages it has suffered since September 30, 2013 as a result of Glaxo's ongoing breach. The Court denied all of GSK's post-trial motions.
The Court awarded Mylan $106.7M in damages after a favorable jury verdict in March 2014. Mylan is the only firm with an FDA-approved generic version of Paxil.
Mylan (NASDAQ:MYL) acquires Abbott Labs' (NYSE:ABT) ex-U.S. specialty and branded generics business for $5.3B in an all-stock transaction. Abbott will receive 105M shares of MYL common stock representing a 21% ownership stake.
The assets include a portfolio of more than 100 drugs that generate ~$1.9B in annual sales. The deal includes a sales force of ~2,000 representatives in more than 40 non-U.S. markets and two manufacturing facilities. The transaction will be immediately accretive to Mylan adding ~$0.25/share to diluted EPS the first year and increasing thereafter.
Reuters reports that generic drug firm Mylan (MYL -1%) is in advanced negotiations with Abbott Laboratories (ABT +0.1%) to purchase a multibillion dollar portfolio of its established off-patent Europe-based drugs. The transaction is a tax inversion deal that will enable Mylan to redomicile in Switzerland.
Mylan has been in the hunt for foreign assets since its failed attempt to buy Swedish drugmaker Meda AB earlier this year. Its two main competitors, (TEVA +0.9%) and Actavis (ACT +0.5%) are domiciled in lower tax countries.
Abbott will use the proceeds of the sale, rumored to be as high as $5B, to invest in higher growth opportunities.
Sun Pharmaceutical Industries voluntarily recalls 41,127 bottles of antidepressant venlafaxine hydrochoride in the U.S. because the pills do not meet dissolution specifications. The recall is classified as Class II which means that the use of the drug may cause temporary or medically reversible adverse health consequences.
Pfizer (PFE) recalled 104,000 bottles of the same drug several months ago after a pharmacist noticed that one of the bottles contained a heart medication. It sells in the U.S. under the brand name Effexor XR.
Sun is also recalling 200 vials of the chemo drug gemcitabine in the U.S. due to a lack of assurance of sterility.
In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
The U.S. District Court of New Jersey finds that Shire's (SHPG) patents protecting ADHD drug Vyvanse (lisdexamfetamine dimesylate) are both infringed and valid in a lawsuit against five would-be generic competitors. The patents are valid until 2023. In order to launch their competing offerings, the generic firms must overturn each of the 18 patent claims (from four Orange Book-listed patents) on appeal.
The ANDA filers are Actavis (ACT), Amneal Pharmaceuticals, Mylan Pharmaceuticals (MYL), Roxane Labs and Sandoz (NVS).
Actavis will be able to launch generic 100 mg and 200 mg dosages in June 2016. The others may launch the same dosages 180 days later. Mylan may launch generic versions of 50 mg, 150 mg and 250 mg dosages beginning in June 2016.
Mylan (MYL -0.2%) launches carboplatin injection, 50 mg/5 ml as a treatment in combination with other chemotherapeutic agents for ovarian cancer. It is a generic version of Bristol-Myers Squibb's (BMY -1.3%) Paraplatin Injection. The company plans to launch three additional dosages in the near future.
According to IMS Health, carboplatin injection generated ~$30M in U.S. sales in the 12 months ending March 31, 2014.
The European Medicines Agency (EMA) reinstates the GMP certificate for India's generic drug maker Ranbaxy Laboratories' Toansa manufacturing site after the company implements corrective measures. The EMA suspended the GMP certificate in January after an on-site FDA inspection discovered significant deficiencies. An EMA inspection team concluded that there was no evidence that any drugs in the EU market containing Toansa-made ingredients were of unacceptable quality or presented a risk to patients.
Mylan (MYL) and Pfizer (PFE +0.5%) settle their suit regarding MYL's ANDA for a generic version of Celebrex (celecoxib). Under the terms of the agreement, MYL may begin selling its version at the earliest market formation but not later than December 2014. No other terms are disclosed.
MYL has appealed the recent ruling by the U.S. District Court for the Northern District of West Virginia affirming rival Teva's (TEVA +2.7%) 180-day exclusivity as the "first filer."